FDA 510(k)

VLP Wrist Fracture System

Número K: K161665 · 2016-11-15

Data da decisão2016-11-15

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VLP Wrist Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K161665. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VLP Wrist Fracture System?

VLP Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161665.

When did VLP Wrist Fracture System receive FDA 510(k) clearance?

VLP Wrist Fracture System received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161665.

Who is the listed applicant for VLP Wrist Fracture System?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VLP Wrist Fracture System?

The FDA product code for VLP Wrist Fracture System is HRS.

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